Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

September 15, 2017

Primary Completion Date

September 28, 2019

Study Completion Date

September 28, 2019

Conditions
Psoriatic Arthritis
Interventions
DRUG

Group A- Tofacitinib

Group A patients will receive Tofacitinib 5mg BD. Patients will be followed up at 1, 3 and 6 months. Patients with inadequate response to Tofacitinib 5 mg BD at the end of 3 months will be put on Tofacitinib 10 mg BD. Primary endpoint for efficacy will be determined by ACR 20 response.

DRUG

Group B- Methotrexate

Group B patients will receive Methotrexate in increasing dose weekly with maximum dose up to 25 mg/week. Patients will be followed up at 1, 3 and 6 months. Patients with inadequate response to highest dose of MTX at the end of 3 months will be put on Tofacitinib 5 mg BD. Primary endpoint for efficacy will be determined by ACR 20 response.

Trial Locations (1)

1205

Bangabandhu Sheikh Mujib Medical University, Dhaka

Sponsors
All Listed Sponsors
lead

Globe Pharmaceuticals Limited

OTHER

NCT03736161 - Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis | Biotech Hunter | Biotech Hunter